An Interventional Left Ventricular Assist System for Cardiogenic Shock

Summary

Imported Impella The price is relatively expensive and difficult for ordinary patients to afford. In order to better meet the growing clinical needs in China, Anhui Tongling Bionic Technology Co., Ltd. has developed an interventional left ventricular assist system. The test device was tested in preclinical animals It has shown good effectiveness and safety. Through the implementation of this clinical trial, the interventional left ventricular assist system The safety and effectiveness of the system for hemodynamic support in patients with cardiogenic shock have led to further development of this product in the country.

Eligibility

For Pre-trial Phase

Inclusion Criteria:

1. Age 18-75 years old;
2. Refractory cardiogenic shock as determined by the cardiac MDT expert group; The criteria for refractory cardiogenic shock are: despite adequate doses of two vasoactive drugs and treatment of the underlying cause, there is still evidence of tissue hypoperfusion;
3. The subject can understand the purpose of the trial, voluntarily participate and sign the written informed consent form reviewed and approved by the ethics committee; the subject agrees to complete the follow-up in accordance with the protocol requirements.

Exclusion Criteria:

1. Right heart failure that meets any of the following conditions:

   a Central venous pressure-capillary wedge pressure ≥10mmHg; b Central venous pressure-pulmonary artery diastolic pressure ≥10mmHg; c Cardiac tamponade.
2. Any peripheral vascular disease that prevents the placement of the trial device;
3. Left or right ventricular thrombus;
4. Aortic valve regurgitation, echocardiographic grade ≥2+;
5. Aortic valve stenosis, valve area ≤1.5cm2;
6. Aortic valve calcification;
7. Presence of mechanical aortic valve;
8. Hypertrophic or obstructive cardiomyopathy;
9. Untreated ventricular septal or atrial septal defect;
10. Patent foramen ovale;
11. Mechanical complications of acute myocardial infarction;
12. Presence of hereditary spherocytosis, hereditary elliptocytosis, autoimmune hemolytic anemia or other diseases that cause hemolysis;
13. Cardiopulmonary resuscitation lasting more than 15 minutes within 24 hours before catheter pump implantation;
14. Ventricular tachycardia or ventricular fibrillation is ineffective with drug treatment;
15. Renal failure, serum creatinine ≥309.4umol/l or blood urea nitrogen ★ ≥35.7mmol/l);
16. Liver failure (total bilirubin ≥85.5umol/l);
17. Allergy or intolerance to heparin;
18. Presence of any cardiac assist device;
19. Presence of active systemic infection;
20. Refusing to sign the informed consent form or failing to complete follow-up as required by the protocol;
21. Pregnant or lactating women, female subjects with potential fertility but unable or unwilling to use effective contraceptive measures during the study;
22. Subjects who have participated in other clinical trials within 3 months or are currently participating in other clinical trials;
23. Other situations that the investigator believes are not suitable for clinical trials.

For Formal Research Phase

Inclusion Criteria:

1. Age 18-75 years old;
2. Low cardiac output syndrome or increased filling pressure after regular continuous pumping of 1 high-dose or 2 medium-dose inotropic drugs within 48 hours after cardiopulmonary bypass was removed during cardiac surgery. The specific criteria are as follows;

The drugs, doses and time of 1 high-dose or 2 medium-dose inotropic drugs are as follows:

Epinephrine: medium dose (\<0.03 μg/kg/min), continuous pumping ≥15 minutes High dose (≥0.03 μg/kg/min), continuous pumping ≥15 minutes; Dobutamine: medium dose (\<5μg/kg/min), continuous pumping ≥15 minutes High dose (≥5μg/kg/min), continuous pumping ≥15 minutes; Milrinone: medium dose (\<0.3 μg/kg/min), continuous pumping ≥120 minutes High dose (≥0.3 μg/kg/min), continuous pumping ≥120 minutes; Low cardiac output syndrome: cardiac index 1.3≤CI≤2.2 L/min/m2;

Increased filling pressure: pulmonary capillary wedge pressure:

20≤PCWP≤30mmHg or pulmonary artery systolic pressure: 25≤PAP≤35mmHg 3) The subject can understand the purpose of the trial, voluntarily participate and sign the informed consent form reviewed and approved by the ethics committee; the subject agrees to complete the follow-up in accordance with the protocol requirements.

Exclusion Criteria:

1. Right heart failure that meets any of the following conditions:

   1. Central venous pressure-capillary wedge pressure ≥10mmHg;
   2. Central venous pressure-pulmonary artery diastolic pressure ≥10mmHg;
   3. Cardiac ascites.
2. Any peripheral vascular disease that prevents the placement of the trial device;
3. Left or right ventricular thrombus;
4. Aortic valve regurgitation, echocardiographic grade ≥2+;
5. Aortic valve stenosis, valve area ≤1.5cm2;
6. Presence of mechanical aortic valve;
7. Hypertrophic or obstructive cardiomyopathy;
8. Untreated ventricular septal or atrial septal defect;
9. Patent foramen ovale;
10. Mechanical complications of acute myocardial infarction;
11. Suffering from diseases that cause increased blood cell fragility or hemolysis;
12. Cardiopulmonary resuscitation lasting more than 15 minutes within 24 hours before catheter pump implantation;
13. Sustained or non-sustained ventricular tachycardia or ventricular fibrillation that is unresponsive to drug treatment;
14. Renal failure, serum creatinine ≥3.5mg/dl or blood urea nitrogen ≥100mg/dl;
15. Liver failure, total bilirubin ≥5mg/dl;
16. Allergy or intolerance to heparin;
17. Other cardiac assist devices other than IABP have been implanted;
18. Active systemic infection;
19. Refuse to sign the informed consent form or fail to complete follow-up as required by the protocol;
20. Pregnant or lactating women, female subjects with potential fertility but unable or unwilling to use effective contraceptive measures during the study;
21. Subjects who are participating in other clinical trials and have not yet reached the endpoints of the trial;
22. Other situations that the investigator believes are not suitable for clinical trials.

Conditions2

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